Metina has internal experts for review and writing of biosimilar application pertaining to USA, EU, BRICS-TM markets and WHO.
- Quality and Scientific Regulatory Services for Global Bio-/Pharmaceutical Industry
Biosimilar Intelligence
Biosimilar Intelligence
- BLA review, scientific writing and submission to CBER, USFDA under 351(k) pathways
- Expert intelligence for biosimilar licensing requirement for national application in BRICS-TM markets
Biosimilar Intelligence - Case Study
Read about vaccine registration and challenges